If you are planning to submit a 510(k) for your medical device to the FDA, you should know that the FDA has tightened their expectations. Consequently, it is more important for you to become familiar with current Refuse to Accept (RTA) policy. Rather than assessing 510 (k) actual contents, the RTA’s purpose is for the FDA to quickly review your submission for completeness.

Following a checklist included in the RTA guidance document, the initial reviewer looks through your 510(k) notifying you of acceptance or rejection within 15 days of submission date. Accepted submissions move forward while rejections come with a completed check list and comments on deficiencies.

When you are formulating your submission, use the RTA checklist to your advantage filling it out referencing where you address each specific question within the 510(k). When you submit the 510(k) paperwork, include your version of the checklist.

Before you submit the 501(k), complete all your sterilization validation and electrical safety and biocompatibility testing including protocols, results and reports. Contrary to leveraging current biocompatibility data on similar materials and processes, submitters must incorporate biocompatibility testing specific to the medical device and combination of processes and materials.

To avoid resubmission, provide all performance test protocols, test data and results because the FDA no longer accepts summaries.

In their submission review, the FDA wants to make sure that you have adequately proven the safety and effectiveness of your device. To speed up device approval, use the same standards and test methods to test directly against the predicate medical device providing the FDA with very detailed information proving that your device is substantially similar to the predicate. Make sure that your device labeling for precautions, warnings, indications and contraindications matches the labeling for the predicate device.

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Many industries have adopted 3D printing as a viable way to custom manufacture components on demand. But the healthcare industry has been slower to move into 3D printing, in part because the Food and Drug Administration hasn’t given medical device companies firm guidance about what the agency requires for products made in this manner. That’s changing. The FDA recently released draft guidance for companies that are working with devices that employ “additive manufacturing” – the process that most people call 3D printing.

The FDA intends its guidance to address design and development, as well as device testing, explains Regulatory Focus. That means that the forthcoming rules should give startup medical device companies a better sense of what they need to do in order ensure their product are in full compliance. But the FDA says that these new rules are not intended to cover any medical devices that contain biologics, cells, or human tissues.

The FDA has signaled openness toward 3D printing techniques. Steven Pollack, director of the FDA’s Office of Science and Engineering Laboratories, told Medical Device + Diagnostics Industry magazine that the agency views 3D printing as a manufacturing technology, not something exotic that regulators haven’t seen before. As a manufacturing technology, Pollack said that 3D printing fits with many of the agencies existing regulations governing medical device manufacturing. The FDA has granted marketing approval to least 85 medical devices made with 3D printing, most of them via existing review pathways, such as 510(k) clearance, he told MD+DI.

With the new guidance, the FDA says manufacturers must also identify each of the steps in the printing process – a requirement made necessary by the various technologies, printers, and materials used in this type of manufacturing. The FDA also says that a 3D printed product should perform the same as a non-3D printed device. For medical device designers and manufacturers, the bottom line is that the FDA is placing its emphasis on ensuring a device’s ability to perform its intended task – regardless of how it is made. That instruction gives medical device designers and manufacturers more clarity on what they need to do to pass regulatory muster.

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Responding to US Homeland Security warning on cyber-attacks of medical devices, the FDA has issued a non-binding guidance document for manufacturers. The FDA acknowledges that device security is the joint responsibility of health care facilities, manufacturers, providers and patients.

Although manufacturers must focus on cyber security throughout design and development, the FDA recognizes that failure to maintain security will impact functionality, data integrity and connected devices and networks. Compromised devices put patient safety and well-being at risk.

Identify: Connected devices are more vulnerable than non-connected devices. Security deployment depends on how the device is employed, electronic interfaces, operating environment, vulnerabilities, likelihood of exploitation and patient risk if breach occurs. Security control design should not impede usability in an emergency.

Protect using these security functions:

Restrict access to trusted users using ID and password, biometrics and smart cards.

Set up automatic session time out appropriate to use.

Restrict privileges based on user or device roles and use multi-factor authenticating for administrators and service personnel.

Avoid using the same password for other devices, passwords that are hard to change or at risk for public disclosure.

Tamper proof with locks for devices and communication ports when possible.

Restrict software updates of the operating system to authenticated users and authenticated code.

Detect and Respond: Devise features that detect, recognize, log, time and react to security compromises. Instruct end-user on post-breach response.

Recover: Design features to protect critical device functions despite compromised security and make sure authorized used are experienced in retention and recovery of device configuration.

The FDA encourages manufacturers to provide the following information in their pre-market documentation:

FDA recommendations for pre-market documentation include listing the cyber security risks examined, listing and defending device security controls and tying controls to risks using a matrix format. Manufacturers should summarize how they will provide software updates for continuing safety and efficacy of the device during life cycle. They should document device integrity beginning to end of production and provide instructions and recommendations for anti-virus software and firewalls.

Onlookers of the medical device market are starting to notice many changes recently. The Food and Drug Administration had issued 20 pre-market approvals by the end of the summer, 43% expansion from a year ago.This validates the agencies purposeful push to speed medical devices to market. The legislature is relying on tax income of close to $30 billion through the following decade to help pay for administrations under the Affordable Care Act.

What’s more, despite the fact that its not clear why tax receipts are beneath projections, the federal government is seeking approaches to discover medical device producers who ought to have paid expenses, yet did not.

The biggest medical device market on the planet, the United States, are hoping to see a 7% or more increment in sales in the coming years. In 2013, the medical device business sector hit $127 billion, with orthopedics being the biggest portion, at around 21%.

The 2.3% excise tax on medical devices that started last year could raise as much as $29 billion for the federal government throughout the following 10 years. Producers will be unable to pass the expense on to their clients, yet may look to their suppliers to ease the burden.

In the mean time, its reasonable that the FDA’s approval isn’t everything. The confirmation that the agency depends on when choosing whether or not to sanction a device doesn’t coincide with information and other variables. For example, choices accessible to patients. In view of the discoveries from Avalere, a Washington-based consultancy firm, business experts are currently urging medical device creators to assemble and give more pertinent data, for example, clinical research trial data, that payers can assess when settling on their choices.

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